Diaphragmmatic Muscle Strength and Balance in Women With... | NCT05885945

Studies
Diaphragmmatic Muscle Strength and Balance in Women With Dysmenorhea

NCT05885945

Sponsor

Catholic University of Murcia

Status

Completed

Last Update Posted

Jan 29, 2024Actual

Enrollment

23Actual

Phase

Not provided

Conditions

Dysmenorrhea Primary

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2023Actual

Primary Completion Date

Jun 14, 2023Actual

Completion Date

Jul 31, 2023Actual

First Submitted Date

May 23, 2023

First Submission Date that Met QC Criteria

May 23, 2023

First Posted Date

Jun 2, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2024

Last Update Posted Date

Jan 29, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Analysis of stabilometric and respiratory variables in patients with dysmenorrhea during the first day of the menstrual cycle and any other day outside the cycle.

Detailed Description

Sociodemographic variables such as age, height, body mass index.

Respiratory variables such as maximum inspiratory pressure (MIP), MIP reference %, and MIP predictive value.

Stabilometric variables we will measure the balance in condition of eyes open and eyes closed bipodal support and eyes open in monopodal support

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dysmenorrhea		primary dysmenorrhea
control		control not pain

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Balance	stabilometric variables in bipodal and monopodal support	2 months
diaphragmatic muscle strength	diaphragmatic muscle force through the maximum inspiratory pressure in the mouth	2 months

Secondary Outcomes

Measure	Description	Time Frame
sociodemographic variables	sociodemographic variables such as age, body mass index, personal data record, and data record related to pain and dysmenorrhea	2 monsths

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult women with primary dysmenorrhea.
Not having had any type of childbirth (natural, caesarean section, etc).
Not be positive in COVID. Antigen test in the last 24 hours or negative PCR in the last 48 hours.

Exclusion Criteria:

Receive medical treatment during research.
Have any orthopedic, neurological or systemic disease diagnosed other than primary dysmenorrhea.
Be in follow-up with any medical treatment that does not be primary dysmenorrhea
Women with a history of trauma or surgical treatment who involve the musculoskeletal system in the last year.
Use of analgesics in the last 48 hours.
Consumption of alcohol in the last 24 hours.
Have a history or suspicion of pregnancy.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

WOMEN WITH PERIOD PAIN

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Women with primary dysmenorrhea

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Felipe León-Morillas	Catholic University of Murcia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Catholic of Murcia		Guadalupe	Murcia	30107	Spain

Condition Browse Module

MeSH Terms

ID	Term
D004412	Dysmenorrhea

Ancestor Terms

ID	Term
D008599	Menstruation Disturbances
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D017699	Pelvic Pain

Browse Leaves

Not provided

Browse Branches

Not provided